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NCT00066690 · OUTCOME

Distant Recurrence-free Interval

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-08-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
5-year estimates, reported at a median follow-up of 67 months.

What was measured

Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.

Analysis population: Intention-to-treat

Groups in this outcome

Tamoxifen

Tamoxifen 20mg orally daily for 5 years

T+OFS

Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

E+OFS

Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Tamoxifen1018
T+OFS1015
E+OFS1014

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tamoxifen90.7Not reported88.692.4Not reported
T+OFS91.3Not reported89.292.9Not reported
E+OFS93.0Not reported91.294.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    estimate Comment
    T was the reference group in the estimation of the hazard ratio.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.40
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    estimate Comment
    T was the reference group in the estimation of hazard ratio.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
Complete source fields
analyses
  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    estimate Comment
    T was the reference group in the estimation of the hazard ratio.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.40
    param Type
    Hazard Ratio (HR)
    param Value
    0.88
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    estimate Comment
    T was the reference group in the estimation of hazard ratio.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        88.6
        upper Limit
        92.4
        value
        90.7
      2. group Id
        OG001
        lower Limit
        89.2
        upper Limit
        92.9
        value
        91.3
      3. group Id
        OG002
        lower Limit
        91.2
        upper Limit
        94.5
        value
        93.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1018
    2. group Id
      OG001
      value
      1015
    3. group Id
      OG002
      value
      1014
    units
    Participants
description
Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
dispersion Type
95% Confidence Interval
groups
  1. description
    Tamoxifen 20mg orally daily for 5 years
    id
    OG000
    title
    Tamoxifen
  2. description
    Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    OG001
    title
    T+OFS
  3. description
    Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    OG002
    title
    E+OFS
param Type
NUMBER
population Description
Intention-to-treat
reporting Status
POSTED
time Frame
5-year estimates, reported at a median follow-up of 67 months.
title
Distant Recurrence-free Interval
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice